Over the past few years, we have seen a surge in the number and frequency in which revisions to the Centers for Medicare and Medicaid Services (CMS) Conditions of Participation (CoPs) for acute care and critical access hospitals were published. As CMS looks to modernize its requirements for participation in the Medicare program, the latest proposed rule released on June 16, 2016 in the Federal Register addresses two major changes (discrimination prohibition and establishment of an infection control and antibiotic stewardship program) and five revision clarifications related to the use of the term “licensed practitioners,” patient access to medical records, quality assessment and performance improvement (QAPI) data requirements, and nursing services.

In this article, we’ll briefly touch on the proposed rule changes, what hospitals should do now to prepare for the changes, and how hospital staff can send comments to CMS about any concerns or questions related to implementation of the revisions. CMS also proposes several technical corrections and some in the Critical Access Hospital (CAH) CoPs that will align them with those for acute care hospitals, such as allowing registered dietitians to prescribe therapeutic diets.

Discrimination Prohibition

While the Hospital and CAH Conditions of Participation (CoPs) require compliance with applicable federal laws related to the health and safety of patients, there is currently no explicit prohibition of discrimination. The proposed rule in the Federal register particularly notes that “LGBT individuals have reported experiencing refusal of treatment by health care staff, verbal abuse, and disrespectful behavior, as well as many other forms of failure to provide adequate care.” Because perceived or actual discriminatory behaviors can affect access to and effectiveness of healthcare delivery, CMS proposes to establish explicit requirements that “the hospital establish and implement a written policy prohibiting discrimination on the basis of race, color, national origin, sex (including gender identity), age, or disability(§482.13). This change would address both discrimination and the research-proven health disparities that result from it.

Antibiotic Stewardship

Almost on the heels of an announcement that a “Drug-Resistant Superbug [was] Found in Pennsylvania Woman (May 28, 2016), CMS’ proposed changes in the CoPs (June 16, 2016) tighten existing requirements to more fully conform to current, nationally accepted infection control and prevention standards of practice. The proposed rule calls for establishing antibiotic stewardship programs (improved and appropriate use of antibiotics) to help reduce inappropriate antibiotic use and antimicrobial resistance – and hospitals and CAHs are required to appoint designated, qualified leaders for those programs. Moreover, “a hospital’s infection prevention and control and antibiotic stewardship programs [ASP] must be active and hospital-wide for the surveillance, prevention, and control of HAIs and other infectious diseases, and for the optimization of antibiotic use through stewardship.” The proposed rules also would specifically require that the hospital QAPI program incorporate quality indicator data, including patient care data submitted to or received from quality reporting, and quality performance programs, including but not limited to data related to hospital readmissions and hospital-acquired conditions. (§482.42) Note that the proposed new name of the CoP will be called infection prevention and control and antibiotic stewardship programs.

According to the Centers for Disease Control (CDC), only 43% of general acute care hospitals, 33% of surgical hospitals, and 18% of critical access hospitals have a comprehensive ASP. The variation is even greater by state, ranging from a high of 58% in California to a low of 7% in Vermont. Hospitals with more than 200 beds have a 59% chance of having an ASP, while only 25% of facilities with fewer than 50 beds have one.

Accredited hospitals and CAHs will want to review The Joint Commission’s (TJC) pre-publication release of a new Medication Management Antimicrobial Stewardship standard (MM.09.01.01) for guidance in establishing their programs. These standards go into effect January 1, 2017.

Revisions and clarifications

In addition to these two major changes, the proposed changes in the CoPs would include the following:

Licensed Practitioners

CMS proposes to change the term “licensed independent practitioner” to simply “licensed practitioner.” Because the Children’s Health Act (CHA) of 2000 (P.L. 106-310) uses the term ‘licensed practitioner’ (LP) rather than the CoPs’ current use of ‘licensed independent practitioner’ (LIP), CMS is proposing to delete the modifying term “independent” from the CoP at §482.13(e)(5), as well as at §482.13(e)(8)(ii), and also proposes to revise the provision to be in keeping with the language of the CHA regarding restraint and seclusion orders and licensed practitioners. Therefore, CMS is proposing that §482.13(e)(5) would now read that the use of restraint or seclusion must be in accordance with the order of a physician or other licensed practitioner who is responsible for the care of the patient and authorized to order restraint or seclusion by hospital policy in accordance with state law. This is a welcome change for hospitals and CAHs, as there is a distinction between licensed independent practitioners and licensed practitioners.

Quality Assessment and Performance Improvement (QAPI) Program

CMS currently requires that hospitals incorporate quality indicator data including patient care data and other relevant data (for example, information submitted to or received from the hospital’s Quality Improvement Organization) into their QAPI programs. In this update, CMS proposes a requirement that the hospital QAPI program also incorporate quality indicator data that includes patient care data submitted to or received from quality reporting and quality performance programs, including but not limited to data related to hospital readmissions and hospital-acquired conditions.

Nursing Services

CMS is proposing the following changes to nursing services. It proposes to revise §482.23(b), which currently states that there must be supervisory and staff personnel for each department or nursing unit to ensure, when needed, the immediate availability of a registered nurse for bedside care of any patient. CMS proposes: 1) to eliminate the term ‘bedside.’ CMS explains that, while it is clearly necessary to have an RN present in an outpatient ambulatory surgery recovery unit, it might not be necessary to have an RN on-site at an off-campus MRI facility at §482.23(b)(7). 2) Thus, CMS further proposes to allow a hospital to establish a policy that would specify which, if any, outpatient departments would not be required to have an RN physically present, as well as the alternative staffing plans established under such a policy. 3) Finally, CMS proposes to revise paragraph (b)(6) to clarify that all nursing personnel (RNs, LPNs, nurse aides, orderlies or other persons under the direction of nursing services) who provide services in the hospital must adhere to the policies and procedures of the hospital regardless of the mechanism through which those personnel are obtained. In addition, the director of nursing services must provide for the adequate supervision and evaluation of the clinical activities of all nursing personnel.

Medical Record Services

The CoPs currently contain requirements to assure that each patient’s medical record contains information to justify all admissions and continued hospitalizations, support the diagnoses, describe the patient’s progress and responses to medications and services, and document all inpatient stays and outpatient visits to reflect all services provided to the patient; and also requires that all patient medical records document discharge and transfer summaries, including any patient discharge instructions. The proposed language changes more clearly articulate the expectations regarding inpatient and outpatient records. Additionally, the proposed change would require that hospitals provide patients with access to their medical records in a form and format requested by the patient, whether electronically or in a hard copy format, if readily producible in that form and format.

Rationale for the Changes

CMS anticipates that its updated requirements will cumulatively result in improved quality of care and improved outcomes for all hospital and CAH patients. CMS believes that the benefits would include:

  • Reduced readmissions
  • Reduced incidence of hospital-acquired conditions (including healthcare-associated infections)
  • Improved use of antibiotics at reduced costs (including the potential for reduced antibiotic resistance), and improved patient and workforce protections
  • Incorporate existing anti-discrimination laws into the CoP, thus reducing barriers to care
  • Improving workforce shortage issues

These benefits are consistent with current HHS Quality Initiatives, including efforts to prevent Hospital Acquired Infections (HAIs); the national action plan for adverse drug event (ADE) prevention; the national strategy for Combating Antibiotic-Resistant Bacteria (CARB); and the Department’s National Quality Strategy.

What should hospitals and CAHs do now?

For the next couple of months, CMS is accepting comments on the proposed rule revisions. However, there are several steps that hospitals and CAHs should begin taking now:

  1. Discrimination prohibition – Revisit your P&P on prohibiting discrimination to ensure it includes the specific wording in the proposed rule (race, color, national origin, sex [including gender identity], age, or disability). Provide education to hospital and medical staff on the effects of healthcare disparities regarding discrimination and access to or availability of facilities and services.
  2. Infection control and antibiotic stewardship program – If you do not have hospital-antibiotic stewardship programs, form a multidisciplinary team consisting of nursing, pharmacy, laboratory, and infection control leaders, staff, and members of the medical staff who are qualified through education, training, experience, or certification for the purpose of establishing the ASP as an organizational priority. There are many initiatives that this team will implement to improve the mindful use of prescribing antibiotics, such as developing protocols, monitoring the use of antibiotics, analyzing prescribing patterns, monitoring antibiotic resistance patterns, and providing feedback to practitioners to guide improved prescription.
  3. Licensed practitioners – Revise your P&P and medical staff bylaws/rules and regulations to replace the term licensed independent practitioner (LIP) with independent practitioner as it relates to restraint orders.
  4. Medical record services – If you do not currently offer patient access to medical records in electronic formats, contact your electronic health record vendor for information on how to implement this process. Also, revisit your list of required elements in the inpatient and outpatient record against the CoP changes.
  5. Quality assessment and performance improvement (QAPI) data requirements – ensure that you are collecting data related to hospital readmissions and hospital-acquired conditions and analyzing the data to identify opportunities for improvement and changes that will lead to improvement.
  6. Nursing services – evaluate your outpatient settings to define when an RN is required to be physically present versus another type of supervisory staff member. Also, clarify in your P&P that all patient care staff (regardless of whether they are employed or contracted) are required to comply with the hospital’s P&P.
To comment:

To be assured consideration, you may submit comments to CMS at one of the addresses provided below, no later than 5 p.m. on August 15, 2016 (60 days after date of publication in the Federal Register).  

ADDRESSES:  In commenting, please refer to file code CMS-3295-P. Because of staff and resource limitations, CMS cannot accept comments by facsimile (FAX) transmission. You may submit comments in one of four ways (please choose only one of the ways listed):

1. You may submit electronic comments on this regulation. Follow the “Submit a comment” instructions.

2. By regular mail. You may mail written comments to the following address ONLY:

Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS-3295-P
P.O. Box 8010
Baltimore, MD 21244

3. By express or overnight mail. You may send written comments to the following address ONLY:

Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS–3295–P, Mail Stop C4–26–05
7500 Security Boulevard
Baltimore, MD 21244–1850.

4. By hand or courier. You may deliver your written comments ONLY to the following address. Note: you must call in advance. Refer to the first page of the Federal Register for specific information.

Centers for Medicare & Medicaid Services,
Department of Health and Human Services
Room 445–G,
Hubert Humphrey Building,
200 Independence Avenue SW.
Washington, DC 20201

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